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Personalizing treatment for patients with HR-positive, HER2-negative metastatic breast cancer using fulvestrant, elacestrant, capivasertib, capecitabine, or a drug combination.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is focused on Metastatic Breast Cancer, which is a type of cancer that has spread from the original breast location to other parts of the body. Specifically, the research looks at a subtype known as HR-positive, HER2-negative cancer. This means the cancer cells have receptors that respond to certain hormones, but they do not have high levels of a specific protein that helps cancer grow. The purpose of the study is to evaluate a new method for choosing the best second-line treatment, which is the next medication used after the first treatment has stopped working. This method uses a liquid biopsy, a way to look for signs of cancer by testing a sample of blood.

Several different medications may be used during the study depending on the results of the blood tests. These include fulvestrant, trastuzumab deruxtecan, capecitabine, capivasertib, and elacestrant. Some of these medications are taken as tablets, while others are given as an intravenous infusion, which is medicine delivered directly into a vein, or as an intramuscular injection, which is medicine injected into a muscle.

During the study, blood samples will be analyzed to find somatic alterations, which are changes in the DNA of the cancer cells. The study will also monitor CTCs, or circulating tumor cells, which are cancer cells that have broken away from a tumor and are traveling through the bloodstream. Participants will receive different treatments based on these findings to see which approach works best for their specific type of cancer.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    After joining the study, a liquid biopsy, which is a blood test used to look for signs of cancer, is performed to guide the selection of the appropriate treatment.

  2. Step 2

    Treatment administration

    One of the following treatment options is provided based on the clinical assessment:

    fulvestrant, administered as a 500 mg intramuscular injection, which is an injection into the muscle.

    trastuzumab deruxtecan, administered as an intravenous infusion at a dose of 5.4 mg per kilogram of body weight. An intravenous infusion is a liquid medicine delivered directly into a vein.

    capecitabine, administered as 2500 mg per square meter of body surface area as oral tablets taken by mouth.

    capivasertib, administered as 800 mg oral tablets taken by mouth.

    elacestrant, administered as 345 mg oral tablets taken by mouth.

Who can join the trial?

15 criteria

  • Female patients, including those who have gone through menopause (the period when menstrual cycles stop) and those who have not.
  • A confirmed diagnosis of adenocarcinoma, which is a type of cancer that starts in the gland cells of the breast.
  • Evidence that the cancer has metastasized, meaning it has spread from the original breast site to other parts of the body.
  • Women who are able to become pregnant must have a negative pregnancy test using highly sensitive blood or urine tests within 7 days before being assigned to a study group.
  • Women who are currently breastfeeding must stop nursing during the time they are receiving the study treatment.
  • The ability and willingness to follow all scheduled appointments, treatment plans, laboratory tests (medical tests that analyze samples like blood), and other study requirements.
  • Providing written informed consent, which is a signed document stating that you understand the study and agree to participate.
  • The cancer must be Estrogen Receptor (ER) positive and/or Progesterone Receptor (PgR) positive. This means the cancer cells have specific proteins that allow them to grow when triggered by hormones. This must be confirmed through immunohistochemistry (IHC), a laboratory method used to detect specific proteins in tissue samples.
  • The cancer must be HER2 negative, meaning the cancer does not have high levels of a specific protein that promotes cancer growth. This is confirmed using special tests called FISH or IHC.
  • You must be at least 18 years old when signing the consent form.
  • The cancer must have progressed, or gotten worse, after receiving at least 6 months of first-line endocrine therapy (hormone treatment) combined with CDK 4/6 inhibitors (a type of drug used to stop cancer cells from dividing).
  • The disease must be evaluable, meaning the cancer can be measured or assessed using standard medical rules called RECIST 1.1 to see if the treatment is working.
  • An ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well a patient can perform daily activities and their overall physical health.
  • Having adequate organ function, meaning the kidneys, liver, and bone marrow (the tissue inside bones that produces blood cells) are working correctly.
  • Women of childbearing potential must agree to avoid pregnancy by either refraining from sexual intercourse or using highly effective contraceptive methods (birth control) during treatment and for at least 6 months after the last dose.

Who cannot join the trial?

11 criteria

  • Being a male.
  • Being pregnant.
  • Having a diagnosis of any other type of cancer within the last 3 years, unless it was a specific, well-treated skin cancer or a very early stage of cervical cancer.
  • Having a known allergic reaction to any of the medicines or substances used in this study.
  • Having a history or current diagnosis of HER2-positive or triple-negative breast cancer, which are specific types of breast cancer defined by certain proteins on the cancer cells.
  • Having already received chemotherapy (medicine used to kill cancer cells) for cancer that has spread to other parts of the body.
  • Having the cancer get worse before completing 6 months of first-line endocrine therapy (hormone therapy used as the initial treatment) combined with CDK 4/6 inhibitors (a specific type of hormone therapy medicine).
  • Having undergone major surgery less than 28 days before being assigned to a study group.
  • Having any ongoing moderate to severe side effects (defined as Grade 2 or higher) from previous treatments or surgeries, such as hair loss or nerve tingling, unless the doctor decides these are not a safety risk.
  • Having an active, uncontrolled infection that is severe, including infections like Hepatitis B, Hepatitis C, or HIV.
  • Having any other uncontrolled illness, such as mental health conditions, that the doctor believes would make it difficult to follow the study rules, increase the risk of adverse events (unexpected medical problems), or make it hard to give official permission to participate.
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Investigated drugs

  • Fulvestrant

    is a medication given as an injection into the muscle. It works by blocking the effects of estrogen, a hormone that can help certain types of breast cancer grow.

  • Trastuzumab deruxtecan

    is a treatment given through an intravenous infusion, which means it is delivered directly into the bloodstream. It is a type of targeted therapy designed to attack specific proteins on cancer cells.

  • Capecitabine

    is a medication taken orally in the form of tablets. It is a chemotherapy drug used to stop the growth of cancer cells.

  • Capivasertib

    is a medication taken orally in the form of tablets. It is used to interfere with specific signaling pathways that cancer cells use to grow and survive.

  • Elacestrant

    is a medication taken orally in the form of tablets. It is a type of hormone therapy that works by blocking estrogen receptors in cancer cells to prevent them from growing.

What is already known about the treatment

  • Fulvestrant

    This medication is an injectable solution administered directly into the muscle to treat certain types of advanced breast cancer. It belongs to a group of drugs called selective estrogen receptor degraders, which work by attaching to and breaking down estrogen receptors in cancer cells to stop them from growing. It is an established treatment used to block the hormones that fuel certain tumors.

  • Trastuzumab deruxtecan

    This medicine is given as an intravenous infusion, meaning it is delivered directly into a vein through a liquid solution. It is a targeted therapy that works by attaching to specific proteins on the surface of cancer cells and then releasing a powerful dose of chemotherapy directly into those cells. It is currently used in medical practice to treat specific types of cancer that express certain markers.

  • Capecitabine

    This medication is taken orally in the form of film-coated tablets. It is classified as a chemotherapy agent that works by converting into an active drug inside the body to interfere with the growth and division of cancer cells. It is widely used in various cancer treatments to slow the progression of the disease.

  • Capivasertib

    This drug is an oral medication taken in the form of film-coated tablets. It belongs to a class of medicines called AKT inhibitors, which work by blocking a specific protein pathway that helps cancer cells survive and multiply. It is currently being studied and used in clinical settings to target specific molecular drivers in cancer.

  • Elacestrant

    This is an oral medication administered through film-coated tablets for the treatment of specific breast cancers. It is a selective estrogen receptor degrader that works by binding to estrogen receptors and causing them to be destroyed, thereby cutting off the cancer's growth signals. This medication represents a targeted approach for patients with specific genetic profiles.

Investigated diseases

Metastatic breast cancer - This is a type of cancer where breast cancer cells have spread from the original site in the breast to other parts of the body. The cells can travel through the bloodstream or the lymphatic system to reach distant organs. As the disease progresses, the cancer cells grow and multiply in these new locations. This process can involve various organs such as the bones, lungs, liver, or brain. The condition is often characterized by the specific biological features of the cells, such as hormone receptor status.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523460-21-00Protocol codeinterACTEstimated enrolment159 patientsSponsorCentro Di Riferimento Oncologico Di Aviano

sourced from the EU Clinical Trials Register and site verification

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